(175 days)
Coloring Liquid is a liquid used for the complete or partial coloration of milled zirconia substructure and anatomy before sintering.
Coloring Liquid is water based, which consist of watery, acidic metal salt solutions. They are used for the individual staining of dental zirconia frameworks and restorations prior to the final sintering of the restoration, enabling the user to adjust the restoration to match the natural color of the patient's teeth. Coloring Liquid is provided in 45 different shades, which are corresponding to patient's closest tooth color. For staining, the zirconia materials have to be immerged into the liquids or to be brushed with the liquids, prior to sintering at high temperatures
The provided documentation is a 510(k) summary for a medical device called "Coloring Liquid." It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through a clinical study involving human subjects or complex algorithms.
Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) regarding sample sizes, expert ground truth, adjudication methods, multi-reader studies, and training sets are not applicable to this type of submission. This document describes a chemical product used in dentistry, not an AI/ML-driven diagnostic or prognostic device.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
The document reports and compares safety testing results, which can be interpreted as demonstrating that the device meets acceptance criteria for biocompatibility.
| Test Description | Acceptance Criteria (Implied) | Reported Device Performance (Subject Device) | Reported Device Performance (Predicate Device K141723) |
|---|---|---|---|
| Cytotoxicity (ISO 10993-5:2009) | No cytotoxicity effect | No cytotoxicity effect | No cytotoxicity effect |
| Irritation Oral Mucosa (ISO 10993-10: 2010) | Not a primary oral mucosa irritant | Not a primary oral mucosa irritant under the conditions of the study | Not a primary oral mucosa irritant under the conditions of the study |
| Sensitization (ISO 10993-10: 2010) | Not a sensitizer | Not a sensitizer under the conditions of the study | Not a sensitizer under the conditions of the study |
| Acute Systemic Toxicity and Subchronic Toxicity (ISO 10993-11: 2006) | No acute and subchronic toxic effects observed | No Acute Systemic Toxicity and subchronic toxic effects observed | No acute and subchronic toxic effects observed |
| Genotoxicity (ISO 10993-3:2003) | No genotoxic effects observed | No genotoxic effects observed | No genotoxic effects observed |
Study Proving Device Meets Acceptance Criteria:
The document states: "Bench testing was performed to ensure that the Coloring Liquid met its specifications. All tests were verified to meet acceptance criteria. Biocompatibility testing was performed to verify the equivalent safety of the materials that are used."
This indicates that internal bench tests and specific biocompatibility tests, following ISO 10993 standards, were conducted to demonstrate the safety of the device. The results of these biocompatibility tests are summarized in Table 5.2. The conclusion drawn is that the subject device's performance in these safety tests is comparable to the predicate device, thus meeting the implied safety acceptance criteria for this type of product.
2. Sample Size Used for the Test Set and the Data Provenance:
- Not Applicable. This submission is for a material (coloring liquid) and focuses on biocompatibility and physicochemical properties, not a diagnostic or AI-powered imaging device that would require a "test set" of patient data in the typical sense. Biocompatibility tests are usually conducted on material samples in controlled laboratory settings (e.g., cell cultures, animal models as per ISO standards). The document does not specify the number of samples or specific animal models used, but refers to ISO standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not Applicable. Ground truth, in the context of device performance, typically refers to a definitive diagnosis or outcome for diagnostic/prognostic devices. For a coloring liquid, "ground truth" would relate to the chemical composition, color properties, and biocompatibility, which are verified through objective scientific methods and established ISO standards, not expert consensus in a clinical reading scenario.
4. Adjudication Method for the Test Set:
- Not Applicable. As there is no "test set" in the context of clinical interpretation, no adjudication method is relevant. Biocompatibility test results are typically interpreted by qualified laboratory personnel following established protocols.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. The device is a "Coloring Liquid" for dental zirconia, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:
- Not Applicable. The device is a chemical product, not an algorithm.
7. The Type of Ground Truth Used:
- Objective Test Results / Standardized Biocompatibility Assays. For this device, the "ground truth" for proving safety and effectiveness (as understood in this context) comes from the results of standardized laboratory tests (e.g., cytotoxicity assays, irritation tests, sensitization tests, systemic toxicity tests, genotoxicity assays) conducted according to recognized international standards (ISO 10993 series). These tests provide objective data on the biological responses to the material.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. This is not an AI/ML device that requires a training set.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.